An online licensing portal of the Central Drugs Standard Control Organization (CDSCO) called “SUGAM” had been launched on last year (14 November, 2015) to file application, submission, processing and Grant permission of registration, import license in a fast and reliable delivery of services.
The following are the Benefits and Limitations of “SUGAM – online portal”
Benefits in SUGAM online portal
- The registration document review, submission and tracking has become much simpler, efficient and transparent with the SUGAM system.
- Helps in keeping track of all past regulatory applications, current applications and future saved applications under one portal.
- Separate icon bars are available for saved, submitted, Approved, rejected registrations for viewing.
- After submitting the application to CDSCO online SUGAM, status bar will show how many days left to get answer from CDSCO
- They have introduced a New Notification Announcement section which displays any new notifications in the last 7 days. This helps in keep track of any updates/changes in the rules.
- It has been made easier to apply for change notifications once the Regulatory Certificate is obtained. This can be done in the section “Post Approval Change”.
- Downloading checklist prior to review is beneficial enabling us to start reviewing the files in the required format making uploading easy.
- If query is raised a message via SMS alert is sent.
- There is no provision to upload files greater than 10MB file size
- Documents need to be split as per each report. Generally companies have information in one single report. For example, Bio-compatibility used to be one topic earlier now it needs to be split into Cytotoxicity testing, acute toxicity etc…
- There is no provision to upload multiple different files for one heading. Companies can only combine them as one PDF giving the possibility of information getting misplaced.
- It is mandatory to upload ALL files even if the document is not applicable. Hence a 1 page doc PDF must be uploaded saying “Not applicable” on the manufacturer’s or Indian agent’s letter head.
- Online Payment is not very clear. Many banks are not listed in their system for net banking.
- There should be a provision to add the timeline / No. of days left to respond to a query raised by the CDSCO.
- There is no provision to download Form 40 once it’s generated. Only at the preview stage there is a provision to download.
Difference between compilation processes:
- In the hard copy compilation labels, IFU, Post Market Study and Batch Release Certificate used to be part of File 1. These documents needed to be notarized. On SUGAM, they are a part of DMF. No particular instructions are given on notary.
- Each part of the PMF is divided into separate sections hence making it important to give information for all sections. Prior to this a standard quality manual for PMF could be submitted, now it needs to be segregated section wise.
- On SUGAM a lot of importance is given to Post Market Surveillance. There are sections of Product Recall, AEs/SAEs and CAPA.
- Clinical investigation- On SUGAM the clinical data is asked in detail. This includes every sub-section like details if clinical investigation, Protocol, Report and Published Literature.
- Biocompatibility– Generally companies submit only the summary of the tests. AS per SUGAM each of the following tests have a report – Cytotoxicity, Sensitization, Irritation, Systematic Toxicity, Subchronic toxicity, Genotoxicity, Implantation, Hemocompatibility etc.
List of Documents Difficult to Prepare and Solution
- Product Classification – It is important to understand how to classify the products. A group of products having same indication of use and material of construction can be classified as one product family. Also a group of products gives constitutes to the overall system comprises of a product family.
- Product Process Verification & Validation – This is always asked by the client. Here they need to give information on mechanical testing, stress testing, engineering tests; laboratory tests; simulated use testing, and any animal tests for demonstrating feasibility or proof of concept of the finished device.
- Shelf life– It is for manufacturers to submit both Accelerated Shelf life and Real Shelf Life
- Sterilization – Many companies submit only the sterilization protocol developed in with e.g ISO 11137. It is important to submit the summary of results, bioburden testing, pyrogen testing, testing for sterilant residues (if applicable) and packaging validation as per recognized standards e.g. ISO 11607.
- Biocompatibility – Generally companies submit only the summary of the tests. AS per SUGAM each of the following tests have a report – Cytotoxicity, Sensitization, Irritation, Systematic Toxicity, Sub chronic toxicity, Genotoxicity, Implantation, Hemocompatibility etc.